Kornimate/medical-research-clean huggingface dataset:
pilot study of t-apcs following car t cell immunotherapy for cd19+ leukemia

Conditions: CD 19+ Acute Leukemia

Summary: patients with relapsed or refractory cd 19+ leukemia who have achieved remission after cd19 car-t cell treatment sometimes relapse because the cd 19 car-t cells decrease in number over time. study plat-03 will test whether administering t cell antigen presenting cells (t-apcs) at intervals following treatment with car-t cells improves cd 19 car-t cell persistence and reduces the incidence of leukemia relapse.

this pilot study seeks to examine the feasibility and safety of administering t cell antigen presenting cells (t-apcs) designed to reactivate and numerically expand cd19-specific car t cells. the underlying hypothesis to be examined is that after remission is achieved with car t cell treatment, the duration, magnitude, and activation state of persisting memory car t cells impact on the potential for durable leukemia eradication. this is of particular relevance in two groups of patients we have identified: those who are predicted to lose persistence of their car t cells before day 63, and those who have definitively lost persistence of car t cells prior to 6 months. by providing these patients with episodic exposure to t-apcs capable of activating cd19-specific car t cells for proliferation and redistribution to tissue beds where tumor cells of all seed, ideally over several months following remission induction, it is posited that the incidence of disease relapse will be diminished.

Eligibility criteria:
inclusion criteria: * diagnosis of recurrent or refractory cd19+ leukemia * adequate performance status * able to tolerate apheresis, including placement of temporary apheresis line if required * adequate renal, liver, cardiac, and respiratory function * adequate absolute lymphocyte count * hiv negative; hepatitis b and c negative within 3 months prior to enrollment. exclusion criteria: * evidence of active clinically significant cns dysfunction * evidence of active malignancy other than cd19+ malignancy * evidence of active gvhd, or on immunosuppressive gvhd therapy within 4 weeks prior to enrollment

Keywords: pediatric young adult acute lymphoblastic leukemia cd 19 leukemia chimeric antigen receptor t cell
adipose-induced regeneration of breast skin to treat post-mastectomy radiation injury in breast cancer patients

Conditions: Breast Cancer

Summary: researchers are trying to identify the therapeutic effect of injection into the subcutaneous tissue to treat radiation-induced skin injury of post mastectomy in patients with breast cancer.


Eligibility criteria:
inclusion criteria: * females above 18 years old * diagnosis with breast cancer, who will be treated by mastectomy and undergo radiotherapy, and will receive breast reconstruction * able and willing to sign consent to participate exclusion criteria: * breast cancer patients that do not accept to participate * patients with previous breast reconstruction surgery
predicton of sepsis recovery performance subtypes pilot study

Conditions: Sepsis

Summary: this study addresses critically ill sepsis patients' current literature reports of ongoing post-hospital discharge weakness and hospital readmissions. this study is aimed at capture and interpretation of a complex set of tests, administered during a subject's sepsis functional recovery trajectory, particularly capturing hospital readmission's effects on survivors' physical function recovery.

patients with sepsis who require icu care, experience frequent weakness, physical dysfunction, fatigue, difficulty concentrating, poor memory, and mental morbidity that persists after hospital discharge. this syndromic pattern has been labeled as post intensive care syndrome (pics) or post sepsis syndrome (pss). these patients are at increased risk of rehospitalization (up to 40% at 6 months). studies have pointed out that sepsis survivors recover within several different recovery patterns or trajectories. unfortunately there are no objective biomarkers early in these patients' hospitalizations, to predict which physical function trajectory a sepsis survivor will experience. however, a very common, unifying symptom of sepsis survivors is weakness. the literature maintains that an intervention of exercise rehabilitation remains a safe and potential therapy for sepsis survivors. it is important to note that as of yet, there has been no benefit demonstrated when highly heterogeneously functioning survivors are included in studies of a uniform rehabilitation intervention. however, for the future designs of icu and post-hospital icu survivor exercise-rehab trials, the field is in need of information on how to label sepsis patients by their predicted outpatient recovery trajectory group, and to be able to do so very proximally in their course, prior to hospital discharge. the intent of this study is to closely track and characterize physical function recovery trajectory groups as a means of informing strategies for effective future study design.

Eligibility criteria:
inclusion criteria: * sepsis requiring organ support in an icu setting exclusion criteria: 1. inability to obtain informed consent 2. the attending physician reports that the patient's goals of care are transitioning to palliation/withdrawal of life-sustaining therapy 3. recent cancer therapy in the last 12 months 4. age \>80 5. plans to be discharged on mechanical ventilation to a long term acute care hospital 6. planned discharge to rehabilitation facility, long-term hospital or nursing home. 7. pregnancy
study of brexucabtagene autoleucel (kte-x19) in participants with relapsed/refractory mantle cell lymphoma (cohort 1 and cohort 2)

Conditions: Relapsed/Refractory Mantle Cell Lymphoma

Summary: the goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (kte-x19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (mcl).

study kte-c19-102 enrolled participants with r/r mcl who have been treated with up to 5 prior regimens including a bruton's tyrosine kinase inhibitor (btki) in cohort 1 and cohort 2. however, to fulfill fda postmarketing requirement, cohort 3 is added to the study. it will include participants with r/r mcl who have been treated with up to 5 prior regimens but have not received prior therapy with a btki. the primary analysis in cohort 1 and cohort 2 is already completed. data for cohort 3 will be analyzed separately. therefore, details for cohort 3 were registered separately (nct04880434) on clinicaltrials.gov as this cohort will not be part of the main study analysis. after the end of kte-c19-102, subjects who received an infusion of anti-cd19 car t cells will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, kt-us-982-5968

Eligibility criteria:
key inclusion criteria: up to 5 prior regimens for mantle cell lymphoma. prior therapy must have included: * anthracycline or bendamustine-containing chemotherapy and * anti-cd20 monoclonal antibody therapy and * ibrutinib or acalabrutinib at least 1 measurable lesion platelet count ≥ 75,000/ul creatinine clearance (as estimated by cockcroft gault) \> or = to 60 ml/min cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (echo), and no clinically significant electrocardiogram (ecg) findings baseline oxygen saturation \>92% on room air. key exclusion criteria: * known history of infection with human immunodeficiency virus (hiv) or hepatitis b (hbsag positive) or hepatitis c virus (anti-hcv positive). a history of hepatitis b or hepatitis c is permitted if the viral load is undetectable per standard serological and genetic testing * history of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (cns) involvement * presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring iv antimicrobials for management. note: other protocol defined inclusion/exclusion criteria may apply.
early protein supplementation of human milk in extremely low birth weight infants

Conditions: Growth in Premature Infants

Summary: we hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protein fortification.


Eligibility criteria:
inclusion criteria: * inborn at mount sinai medical center * gestational age between 26 0/7 weeks and 32 6/7 weeks gestation * plan by family for their infant to receive human milk feeds exclusion criteria: * outborn infants * gestational age \ 33 0/7 weeks * major congenital anomalies including cardiac disease, inborn errors of metabolism etc. * sepsis and/or other serious clinical complication precluding initiation of enteral feeds * plan by family for their infant to receive primarily preterm infant formula.
menopausal symptoms in women with breast cancer or at high risk of breast cancer treated on another clinical trial

Conditions: Breast Cancer; Hot Flashes

Summary: rationale: gathering information about the frequency and intensity of hot flashes in patients with breast cancer and in patients who have a high risk of developing breast cancer may help doctors learn more about menopausal symptoms. purpose: this clinical trial is looking at menopausal symptoms in women with breast cancer or at high risk of breast cancer who received treatment on another clinical trial.

objectives: * retrieve data from an archived database of a closed clinical trial that involved treatment with sertraline hydrochloride or a placebo for the management of hot flashes or other menopausal symptoms in women with breast cancer or at high risk of breast cancer. * analyze the results of this closed clinical trial so that they can be published. outline: data from an archived database of a closed clinical trial is retrieved. descriptive analyses of outcome variables (e.g., menopausal symptoms, including number and intensity of hot flashes, and psychosocial and quality of life scales) are conducted to gain insight into their distributional aspects. data is analyzed using anova with repeated measures to account for the changes within a patient over time as a function of treatment assignment. summary scores from the psychosocial scales that are reasonably complete (i.e., fact-b and poms) are examined using mixed linear models to account for patient-specific differences, treatment effects, and variable patterns of completeness.

Eligibility criteria:
disease characteristics: * personal or family history of carcinoma in situ of the breast or invasive breast cancer * treated with sertraline hydrochloride or a placebo on a clinical trial (that is now closed) at the baylor college of medicine-the methodist hospital breast cancer center * reported hot flashes with a hot flash rating of \> 15 (frequency and severity) for 1 week (before starting treatment with sertraline hydrochloride or a placebo) * no progressive metastatic breast cancer * hormone receptor status not specified patient characteristics: * female * menopausal status not specified prior concurrent therapy: * see disease characteristics

Keywords: breast cancer in situ stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer hot flashes
polygraphic evaluation of the effects of different rapid maxillary expansion appliances on sleep quality

Conditions: Sleep Apnea Syndromes; Palatal Expansion Technique

Summary: rapid maxillary expansion (rme) is a commonly used orthodontic treatment in patients with maxillary constriction to provide skeletal expansion, correct posterior crossbite and resolve naso-respiratory problems by reducing oral respiration.the aim of this randomized controlled trial was to evaluate the effects of tooth-borne, tooth tissue-borne and bone-borne rme appliances on sleep quality with polygraphy. the null hypothesis was that there is no difference for the sleep quality between the appliances.

introduction. the aim of this 3-arm randomized controlled trial (rct) was to evaluate the effects of tooth tissue-borne (kbme), tooth-borne (hyrax), and bone-borne (midme) rapid maxillary expansion (rme) appliances on sleep quality with polygraphy. methods. this study was designed in parallel with an allocation ratio of 1:1:1. 46 patients with narrow maxilla and osas were included in this study and randomly assigned to three groups: tooth tissue-borne, tooth-borne and bone-borne expanders. participants were congregated from the department of orthodontics, faculty of dentistry, izmir katip celebi university, turkey. in all groups, the expansion appliance was activated one-quarter turn twice a day until the desired suture opening was achieved. the primary outcome of this study was the correction of posterior crossbite. secondary outcomes included polygraphic assessment of sleep parameters. each subject participated in 1 overnight sleep test with polygraphy before the expansion (t0) and after a 3-month retention phase of treatment (t1). according to the results of polygraphy, 7 parameters; (apnea hypopnea index (ahi), number of apnea and hypopnea, desaturation index, lowest desaturation, average saturation, supin ahi) were examined to evaluate the changes in sleep scores. kruskal-wallis analysis and dunn-bonferroni test were used for inter-group comparisons and wilcoxon analysis was used for intra-group evalaution. p\<0.05 was accepted statistically significant. computer-generated randomization was used with group allocation concealed using opaque, sealed envelopes. the outcome assessor was blinded to group assignment. the outcome assessor was blinded; however, it was not feasible to blind either operator or patients.

Eligibility criteria:
inclusion criteria: 1. no previous tonsillar, nasal or adenoid surgery and orthodontic treatment, 2. bilateral crossbite and need for rme, 3. maxillary and mandibular permanent teeth fully erupted, 4. willingness to participate in the study exclusion criteria: 1. the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy 2. having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene, 3. history of previous orthodontic treatment.

Keywords: polygraphy obstructive sleep apnea rapid maxillary expansion
combination of ranibizumab and verteporfin therapy in neovascular age-related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration

Summary: the purpose of this study is to evaluate changes in preferential hyperacuity perimeter (php) and fundus autofluorescence (faf) in patients with neovascular age-related macular degeneration receiving combination of ranibizumab (lucentistm) and verteporfin (visudyne®) therapy


Eligibility criteria:
inclusion criteria: * signed written informed consent * age ≥ 50 years old * patients with primary active subfoveal cnv secondary to amd * baseline best-corrected visual acuity (bcva) in the study eye was from 20/40 to 20/400 using etdrs chart * characteristics of amd lesion * predominantly or minimally classic, or occult * absence of prior subfoveal treatment for macular disease * total lesion size ≤ 9 optic disc areas, with cnv component ≥ 50% of the lesion (unless a serous pigment epithelial detachment was present, in which case \< 50% cnv was acceptable) * active choroidal neovascularization leakage * submacular blood \< 50% and subretinal fibrosis \< 25% of the total lesion exclusion criteria: * additional eye disease that could compromise va * cnv unrelated to amd * ocular inflammation * vitreous hemorrhage * retinal hemorrhage (other than amd related submacular blood) \> 1 disc areas * intraocular surgery ≤ 1 month before day 0 * uncontrolled glaucoma * prior treatments with verteporfin pdt * laser photocoagulation or other intervention for amd * previous treatment with external-beam radiation therapy or transpupillary thermotherapy * history of vitrectomy
feasibility of using contrast enhanced voiding urosonography (cevus) during urodynamic studies

Conditions: Neurogenic Bladder

Summary: the investigators will assess the feasibility of replacing fluoroscopy/iodinated contrast with ultrasound/sulfur hexafluoride lipid-type a microspheres during routine urodynamic studies.

urodynamic studies routinely involve instillation of iohexol (omnipaquetm), a low osmolality contrast agent, into the bladder followed by fluoroscopic imaging to assess for reflux or variant anatomy of the genitourinary system. recently, sulfur hexafluoride lipid-type a microspheres (lumasontm), an ultrasound contrast agent, has been approved in the united states for intravesicular administration in the pediatric population. contrast enhanced voiding urosonography (cevus) is being increasingly utilized in the place of voiding cystourethrograms, with the major advantages being decreased (zero) radiation for the patient, as well as decreased cost. given the similarity in procedure between urodynamic studies (uds) and voiding cystourethrograms, the investigators hypothesize that a urodynamic study may be performed with contrast enhanced ultrasound instead of fluoroscopy. the investigators plan to conduct a small feasibility study by recruiting a group of 30 patients under the age of 18, who are willing to undergo their normally scheduled uds in addition to cevus. the uds typically consists of two cycles of bladder filling and voiding; the investigators intend to replace the use of fluoroscopy and iohexol with ultrasound and sulfur hexafluoride lipid-type a microspheres. this will decrease the time commitment and eliminate radiation exposure for the patient. there will not be a formal analysis of data as the investigators are planning to test the feasibility of the procedure rather than gather any quantitative data. the goal of the study is to eventually implement cevus instead of fluoroscopy in all urodynamic and voiding studies if it is found to be a reasonable alternative. this will decrease pediatric radiation exposure, which will be especially important in the patients undergoing several studies each year.

Eligibility criteria:
inclusion criteria: * age 0-18 * must have had prior urodynamic study at university of virginia exclusion criteria: * pregnant women * fetuses * neonates * prisoners * subjects with preexisting cardiac conditions (such as heart failure and ventricular arrhythmias) * subjects with a known hypersensitivity to lumason

Keywords: contrast ultrasound urodynamics
allergic rhinitis changes the sinus microbiome

Conditions: Seasonal Allergic Rhinitis

Summary: the investigators hypothesize that treatment with qnasl will reduce nasal mucosal inflammation induced by the allergy season and prevent the changes in the microbiome caused by the allergy season.


Eligibility criteria:
inclusion criteria: 1. males and females between 18 and 55 years of age. 2. two year history of seasonal allergic rhinitis. 3. positive skin test to grass and/or tree antigen. exclusion criteria: 1. physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. 2. pregnant or lactating women. 3. subjects treated with systemic steroids during the previous 30 days. 4. subjects treated with topical (inhaled, intranasal or intraocular) steroids, nasalcrom or opticrom during the previous 30 days. 5. subjects treated with oral antihistamine/decongestants during the previous seven days. 6. subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days. 7. subjects treated with immunotherapy and are escalating their dose. 8. subjects on chronic anti-asthma medications. 9. subjects with polyps in the nose or a significantly displaced septum. 10. upper respiratory infection within 14 days prior to study start.
intraoperative cell saver autotransfusion use for major surgical oncology operations.

Conditions: Pancreaticoduodenectomy; Pancreatectomy; Esophagectomy; Gastrectomy; Hepatectomy

Summary: the purpose of this study is to demonstrate the safety and benefit of auto-transfusion filtered blood in patients undergoing major surgical oncology procedures.

homologous blood transfusions during surgical procedures are becoming more challenging, due to lack of adequate reserves and the significant risks of transfusion reactions. recent advances in the use of patient's own blood (autologous transfusion) has rapidly gained acceptance in major surgical procedures, however due to the requirement for prior planning and the expense of obtaining and storing a patient's blood prior to surgery this alternative is less than ideal. this research study utilizes a third alternative, a technique called intraoperative autotransfusion, which successfully salvages a patient's blood during surgery and reinfuses the blood back into the patient. the blood salvaging device uses a filtration device that successfully filters out all tumor cells to prevent re-infusion of viable cancer cells. this study is designed to demonstrate the safety and benefits of the blood salvaging device on patients undergoing major surgical oncology procedures.

Eligibility criteria:
inclusion criteria: 1. subject is undergoing a major surgical oncology procedure and has potential for extensive blood loss. 2. subject is ≥ 18 years of age. 3. subject or subject's legally authorized representative (lar) has signed an irb-approved informed consent form. exclusion criteria: 1. subject has medical, social, or psychological factors that, in the opinion of the investigator, could impact safety or compliance with study procedures. 2. subject is \< 18 years of age. 3. subject or subject's lar did not sign irb-approved informed consent form.

Keywords: cell saver liver tumors liver cancer surgical oncology whipple blood transfusion blood salvage cancer surgery blood loss